Phase 3 Trials of Inhaled Treprostinil for Idiopathic Pulmonary Fibrosis

Based on preclinical and clinical evidence of an antifibrotic mechanism, two Phase 3 randomized trials of treprostinil as inhaled prescription therapy were conducted for treatment of idiopathic pulmonary fibrosis (IPF). The publication reports the results of the double-blind TETON 1 trial, in which patients with IPF were randomly assigned the inhalation of the experimental drug or a placebo at a target dose of 12 breaths for 4 times daily. The primary focus of the study was to measure the change from baseline in absolute forced vital capacity (FVC) after 52 weeks to evaluate how much the therapy helped preserve lung function. The team also recorded secondary measures of success, such as outcomes for clinical worsening. For example, these included occurrences involving loss of life, respiratory hospitalization, or a relative FVC decline greater than 10%, acute exacerbations, and overall efficacy and safety outcomes. Treatment with inhaled treprostinil successfully led to smaller decline in FVC and fewer clinical-worsening events than the placebo group over the course of 52 weeks.